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XTEND-15sec-NEWSt
19th November 2004

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Is Vitamin E dangerous in high doses?n1

You may have read the issue of Xtend-Your-Life earlier this week that addressed the current news about Vitamin E. In case you missed it you can access it via our archives in issue 16th November 2004.

The article deals with claims by researchers of a meta analysis that excessive Vitamin E could possibly increase the risk of dying prematurely. As a further back up to Warren Matthews article you may wish to read a letter posted on the NPI newscenter website by Neil E. Levin, CCN, DANLA. It reinforces Warren's article but expands on it a bit further. To read the posting please click here.

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FDA failed public on Vioxx, official says!n2

Congress probes agency on arthritis drug safety warnings.

At a Senate Finance Committee on Nov. 18, government drug reviewer Dr. David Graham said FDA's handling of Merck & Co Inc.'s withdrawn painkiller Vioxx, is a 'profound regulatory failure' by an agency 'incapable of protecting America' from another dangerous drug. This is what MSNBC say in one of their lead articles today.

To see the rest of it please click here.

Warren Matthews comments: Hmmm... what can I say that Dr Graham has not already said except that this just reinforces how important it is that you take charge of your own health and when prescribed pharmaceutical drugs... question your Doctor as to ALL the implications... and then question again!

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Pfizers get a rap on the knuckles!n3

WASHINGTON (Reuters) - Two television advertisements for Pfizer Inc.'s (PFE.N: Quote, Profile, Research) impotence drug Viagra should be withdrawn for claiming a return of sexual desire and omitting key information, the Food and Drug Administration said in a letter to the company released on Monday.

The ads, with a voice-over that includes "Remember that guy who used to be called 'wild thing'?" and later says "He's back," failed to mention major side effects and why certain patients should not take Viagra, the FDA said.

The FDA's letter, dated Nov. 10, also said the 30- and 15-second ads omit to mention that Viagra is intended to treat erectile dysfunction and the claim of return to a previous level of sexual desire and activity is unsubstantiated.

"If you have data substantiating this claim, please submit them to FDA for review," the letter said.

Pfizer did not immediately return a call seeking comment.

The FDA's Division of Drug Marketing, Advertising and Communications said Pfizer should immediately cease using the offending ads and any similar promotions. It asked the company to respond by Nov. 24 on its intent to comply.

Warren Matthews comments: I find it a little odd that the FDA should target Viagra in this way and yet ignore other ads which also give misleading impressions.

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Important notice: All material provided within XTEND-15sec-NEWS is for informational and educational purposes only, and is not to be construed as medical advice or instruction. No action should be taken solely on the contents of this publication. Consult your physician or a qualified health professional on any matters regarding your health and wellbeing or on any opinions expressed within this newsletter. The information provided in this newsletter is believed to be accurate based on the best judgment of the editor but the reader is responsible for consulting with their own health professional on any matters raised within.





Is Vitamin E dangerous in high doses? (Full Article)f1
Posted: 12 Nov 2004 10:26 AM

In some circumstances, it may be. But these are limited conditions and there are certainly some easy ways to get around them. Let me explain.I am writing this in response to an article to be published this week in Annals of Internal Medicine. Researchers at Johns Hopkins have subjected some Vitamin E studies to a meta-analysis, which is where previously published studies are re-examined and compared in order to try to mine more information out of them. These meta-analyses are often highly speculative, because the protocol for each study is different enough that it becomes a stretch to link the results and imply a common thread runs through them despite the different variables. For example, the supplement tested may be given in different forms or doses, the patient group may have significant differences, the length of time taking the supplement may vary considerably or may even include previous users and new users, etc. There are also differences between natural and synthetic Vitamin E, with most studies using only the synthetic forms that are composed of different-shaped molecules and only half as effective as natural Vitamin E. Natural Vitamin E is called d-alpha tocopherol and synthetic Vitamin E is called dl-alpha tocopherol.

Official U.S. dietary guidelines set an upper tolerable intake limit of up to 1,500 IU per day, based on the scientific record.

While these meta-analyses are academically useful to point to potential new problems or solutions, by no means are they definitive proof of anything, due to the lack of uniform protocols and patient groups. But that won't stop the medical lobby from trying to use these results to limit potencies of vitamins to everyone "for our own good". The doctors and researchers may be well-meaning, but results of this kind of preliminary study can be publicized and take on a life of their own, with a new role as "proof" of the dangers of taking vitamins.

One thing that many of the patients in this analysis of previous studies had in common was being elderly and sick. So the first caution issued by the report's authors is that their speculative findings would not even apply to healthy or younger people. That's one BIG argument against using this analysis to set general restrictions on Vitamin E dosages. We already have some evidence that taking one antioxidant, rather than antioxidant formulas or multiple vitamins, may increase the cancer risks for aged smokers. This may be because antioxidants need to recharge and support each other or else some can actually transform into pro-oxidants that can increase the damage.

I always caution against taking mega-doses of one nutrient without considering potential side effects. Taking only one antioxidant may seem to deplete others because of the way they interact, with one antioxidant chemically supporting others. A surplus of one nutrient may increase a person's need for one or more other nutrients, creating an apparent functional deficiency.

There is a recent example that illustrates my point. Some years ago an antioxidant study in Finland was halted early, with a widely reported increase in cancer rates among male smokers taking beta-carotene. Headlines associated vitamins with cancer risk. Despite objections that the study was flawed, vitamin use dropped.

Fast-forward to this year. A new analysis published in July takes another look at that same Finnish smokers' study, but now takes into account their total antioxidant intake, and clears up that whole controversy. Their risk of getting lung cancer was closely associated with total antioxidants in the diet, with more antioxidants meaning less cancer.

A composite antioxidant index was generated for each of the 27,000 men over 14 years. The calculated amounts of carotenoids, flavonoids, Vitamin E, selenium and Vitamin C were compared to actual lung cancer rates, with a clear result: a combination of antioxidants lowers lung cancer risk in male smokers.

What does this all mean? I think we are in for another round of attacks on vitamins based on this crude analysis of Vitamin E, with some medical experts calling for restrictions on vitamin potency. That would be a mistake, both scientifically and from a public health viewpoint. The message should be that people should not try to take a high dose of one supplement without considering that it may increase our need for other nutrients. Elderly, sick people need a more holistic approach rather than using a single nutrient in high doses, as if it were a drug. Nutrients just don't work well in isolation from each other. Vitamins are essential to health and life, but the average American gets only 1/3 of the recommended daily intake of Vitamin E that would prevent serious illnesses. Most people would benefit from taking a multiple vitamin and a Vitamin E supplement, and it would be safer than just the Vitamin E alone.

That shouldn't be hard for the smart folks at Johns Hopkins to understand.

By Neil E. Levin, CCN, DANLA

REFERENCES:

  1. July 2004 American Journal of Epidemiology.

  2. 2. Poster session abstract: High-dose vitamin E supplementation may increase all-cause mortality, a dose response meta-analysis of randomized trials; Ernest N. Morial Convention Center, Exhibit Hall 1-2.) TO BE PUBLISHED: Annals of Internal Medicine, Nov. 10, 2004.

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FDA failed public on Vioxx, official says (Full Article)f2
Congress probes agency on arthritis drug safety warnings

At a Senate Finance Committee on Nov. 18, government drug reviewer Dr. David Graham said FDA's handling of Merck & Co Inc.'s withdrawn painkiller Vioxx, is a 'profound regulatory failure' by an agency 'incapable of protecting America' from another dangerous drug.

WASHINGTON - The American public is "virtually defenseless" if another medication such as Vioxx proves to be unsafe after it is approved for sale, a government drug safety reviewer told a congressional committee Thursday.

The U.S. Food and Drug Administration failed the public in its oversight of Merck & Co Inc.'s withdrawn painkiller Vioxx and is "incapable of protecting America" from another dangerous drug, agency researcher David Graham told Congress.

"I would argue that the FDA as currently configured is incapable of protecting America against another Vioxx," said Graham, who had warned that the arthritis drug had been linked to an increased risk of heart attack and stroke.

He called the FDA's actions "a profound regulatory failure."

Concerns about a possible link between Vioxx and heart problems were building during the drug's more than four years on the market. The FDA required a warning about heart risks but felt the drug's benefits made it worth keeping on the market.

Merck Chief Executive Raymond Gilmartin said the company had believed wholeheartedly in Vioxx and had followed a rigorous scientific procedure every step of the way.

"In fact, my wife was taking Vioxx, using Vioxx, up until the day we withdrew it from the market," Gilmartin told the Senate Finance Committee.

Other dangerous drugs

Graham told the committee that there were at least five other drugs on the market today that should be looked at seriously to see whether they should remain there. He cited the acne drug Accutane, the weight loss drug Meridia, the anti-cholesterol drug Crestor, the pain reliever Bextra, and the asthma drug Serevent.

AstraZeneca Pharmaceuticals, maker of Crestor, said it was confident that the drug was safe. "To date, the FDA has not given us any indication of a major concern regarding Crestor," said spokeswoman Emily Denney.

Another official, Dr. Sandra Kweder, said that she did not agree with Graham's assessment with the risk posed by the five drugs singled out by Graham. She said "there is no magic formula" to determine the drugs that pose the most pressing safety concerns.

She said there are thousands of drugs on the market, each one carrying risks and benefits. "That is clearly Dr. Graham's opinion" regarding the five drugs, she said, denying that the FDA intimidates scientists whose opinions differ with superiors.

Merck pulled the drug from the market on Sept. 30 after a study indicated the popular painkiller doubled the risk of heart attacks and stroke when taken for longer than 18 months.

Raymond V. Gilmartin, the company president, said in prepared testimony that Merck acted within four days of learning about the risk.

"Given the availability of alternative therapies and the questions raised by the data withdrawing Vioxx was consistent with an ethic that has driven Merck actions and decisions for more than 100 years," he said.

The FDA has defended its actions regarding Vioxx. In a statement issued late Wednesday, the agency cited its "well-documented and long-standing commitment to openness and transparency in its review of marketed drugs."

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